(1) Field
The present inventions relate generally to drug delivery systems and, more particularly, to a device for use during breastfeeding to introduce agents directly into the milk stream.
(2) Related Art
Currently the World Health Organization recommends that, “when replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breastfeeding by HIV-infected mothers is recommended. Otherwise, exclusive breastfeeding is recommended during the first months of life.” This is because using formula in low-resource settings has been shown to decrease infant survival due to increased numbers of deaths from diarrhea and malnutrition (Brahmbhatt, 2003). In terms of specific breastfeeding recommendations, the situation is ambiguous. Some of the most recent published data from a study of exclusive breastfeeding followed by rapid weaning in Zambia has shown no benefit for the intervention group compared to a control group that followed traditional breastfeeding practices. About 7% of infants in both groups became HIV infected via breast milk between four and 24 months of age.
Another recent study has shown that giving anti-retroviral medications (ARVs) to a breastfeeding infant could reduce HIV transmission. However, the use of ARVs may lead to the evolution of resistant viruses, which would complicate eventual treatment of acquired immunodeficiency syndrome (AIDS) in infants that become infected despite the use of prophylactic ARVs. Despite these issues, the most promising current strategy to prevent HIV transmission through breast milk appears to be prophylactic treatment of breastfeeding infants with ARVs.
It would be advantageous to prevent HIV without the use of ARVs and without interrupting normal breastfeeding patterns. One approach for protecting infants is to have mothers express their breast milk into a container, heat the breast milk, i.e. an abbreviated pasteurization process, and feed it to the baby using a spoon or a bottle. However, this disrupts normal breastfeeding patterns and is impractical and burdensome for mothers living in low-resource settings.
A number of inventions have proposed the use of a modified pacifier or baby bottle nipple to deliver liquid medications to an infant. However, the preparation of formulations for administration to infants as liquids is complex and time consuming, and putting medications in a fluid greatly reduces their stability and usually requires refrigeration.
It is to these and other problems that the instant disclosure is directed. In particular, Applicants have identified a need for devices capable of delivering therapeutic or prophylactic formulations during breastfeeding. In one embodiment, this device is simple to manufacture and use, lightweight, relatively inexpensive, discreet, and effective. Typically, such devices should be able to inactivate or kill HIV in breast milk in a way that is convenient and entails minimal disruption of breastfeeding. It would also be advantageous to have a method to prepare and store a medication in a dry form that does not require dissolution by a pharmacist before administration, and can be easily dissolved one dose at a time.